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Effectiveness of Technology-Supported Hand Strengthening and Stretching Exercises in Patients With Rheumatoid Arthritis

Development, Feasibility, and Effectiveness of Smartphone Application for Hand Therapy for Patients With Rheumatoid Arthritis: Mix Method Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04365842
Enrollment
40
Registered
2020-04-28
Start date
2019-11-02
Completion date
2020-08-30
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

mhealth, hand exercise, rheumatoid arthritis

Brief summary

Growing research evidence supports the effectiveness of mHealth interventions for improving exercise adherence and motivation. The aims of our study are; 1) to develop and design a smartphone application for a structured hand exercise program for patients with RA and to test its usability. 2) Evaluate the feasibility and effectiveness of hand exercise app. This study is a mixed-methods study that aims to investigate the effectiveness of the Mar-HandTherapy app: a qualitative and quantitative study with the iterative design approach.

Detailed description

The long-term beneficial effects of strengthening and stretching for rheumatoid arthritis (RA) for hand programs (SARAH) on functions have been shown in recent studies. Also, recently a usable web-based hand exercise program developed for patients with RA in UK. 1- The aim of our study is to develop and design a smartphone application for structured hand exercise program for patients with RA and to test its usability. 2- Evaluate the feasibility and effectiveness of smartphone app hand exercise app. In our study, a qualitative iterative design approach that includes focus groups of experts/patients was used. The mobile application was designed in 3 phases: PHASE 1: we conducted focus group meetings to compromise the content, feature and design of app in the first phase (Prototype version of smartphone software for RA hand training program/Mar-Hand-Therapy app). Focus Group were consisted two physiotherapist (PT), three hand therapists (HT) working in the field in different rheumatology or hand rehabilitation clinics, two software-computer engineers, 3 patients with RA who had previously participated hand therapy. All focus group members (n=10) and 6 patients used the app for one week. All users filled the usability questionnaire, made the comments and advises. The revised version was tested again for one week. The last revised version completed after two weeks tested. 40 patients diagnosed with rheumatoid arthritis will be included to the study. Participants randomized to digital intervention and waiting list control. After the 6-week digital intervention qualitative interviews have done with 6-15 patients from intervention group to assess the feasibility of digital intervention. The primary outcomes are hand pain and function and exercise adherence.

Interventions

BEHAVIORALDigital exercise group

Hand Rehabilitation Program: Developed hand exercise smartphone app which include: Self-assessment, (b) self-monitoring (c) exercises types/frequency/ diary, (d) patient education, (e) behavioral change and encouragement (f) exercise adherence Sample exercises 1. Hand and finger movements: 6-8 repetitions, according to the diagnosis of the patient 2. Strengthening exercises of hand and finger muscles 3. Exercises to increase grip and pinch strength 4. Exercises to increase tendon swing and pull angle

OTHERGeneral Home Hand Therapy

Hand rehabilitation home program will be given to the through the telephone messages with brochures. 1. Hand and finger movements: 6-8 repetitions, according to the diagnosis of the patient 2. Strengthening exercises of hand and finger muscles 3. Exercises to increase grip and pinch strength 4. Exercises to increase tendon swing and pull angle

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Those diagnosed with rheumatoid arthritis according to ARA criteria * RA patients with stage 2 or 3 according to ACR criteria * The first symptoms started at least a year ago and those who are undergoing medical treatment * Those between the ages of 18-65

Exclusion criteria

* Those who are in the inflammatory period * Those who have had surgery for neurological, orthopedic or other reasons recently * Those with specified depression or other psychological diagnosis * Those who have received physiotherapy and ergotherapy in the past year

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline of Hand pain at 7 weekBaseline and week 7Measurement of health perspective with 100 mm visual analogue scale (VAS). We assess the hand pain score change from baseline scores at 7th week. The leftmost value in the 100mm horizontal line used for VAS is scored between 0 mm (no pain) and the rightmost value is rated between 100mm (unbearable pain).
exercise adheranceweek 7Qualitative data from smartphone (Time using the app, times of using videos etc)

Secondary

MeasureTime frameDescription
Change from baseline of Hand FunctionBaseline and week 7Measure of Activity Performance in the Hand (MAP-HAND). It consists of 18 questions. Each question scores between 0 and 3 points. It worsens as the total score increases.We assess the hand function score change from baseline. scores at 7th week.

Countries

Turkey (Türkiye)

Contacts

Primary ContactEda Tonga, PhD
eda.tonga@gmail.com+905323275451

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026